Cerebral Palsy (CP)ASI-CP-PTNCT07895485
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
A study testing Ayres Sensory Integration-Based Physiotherapy and Usual Physiotherapy and Rehabilitation in people with Cerebral Palsy (CP), run by Izgi Miray Demirbag.
Trial summary
This study will examine whether a 12-week Ayres Sensory Integration (ASI)-based physiotherapy program can improve motor skills and daily functioning in young children with cerebral palsy. Thirty children aged 3 to 6 years who meet the study criteria will be assigned to an intervention group or a control group. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Ayres Sensory Integration-Based Physiotherapy and Usual Physiotherapy and Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 6 years.
- Diagnosis of cerebral palsy, classified as Level I or II according to the Gross Motor Function Classification System (GMFCS).
- Written informed consent provided by a parent or legal guardian.
- No major visual or hearing impairment that would interfere with the assessments or intervention.
Who cannot join
- GMFCS Level III, IV, or V.
- A severe orthopedic condition that could prevent participation in the intervention.
- Uncorrected visual or hearing impairment.
- Use of sedative medication that could affect the assessments or intervention.
- Epilepsy.
- Any other medical condition that could prevent safe or appropriate participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Ayres Sensory Integration-Based Physiotherapy in Children With Cerebral Palsy: A Randomized Trial
This study will examine whether a 12-week Ayres Sensory Integration (ASI)-based physiotherapy program can improve motor skills and daily functioning in young children with cerebral palsy. Thirty children aged 3 to 6 years who meet the study criteria will be assigned to an intervention group or a control group.
Children in the intervention group will receive 36 sessions of ASI-based physiotherapy over 12 weeks. Each session will last 60 minutes and will be provided by a physiotherapist certified in ASI. Children in the control group will continue their usual physiotherapy and rehabilitation and will not receive additional ASI as part of the study.
Children will be assessed before and after the 12-week study period. Assessments will include measures of motor skills, development, daily activities, sensory processing, and progress toward individual goals. The Evaluation in Ayres Sensory Integration (EASI) will be completed before the intervention only. Assessments will be carried out in a clinical setting by an assessor who is independent of the therapists providing the intervention.
Read the detailed description
This study will evaluate the effectiveness of an Ayres Sensory Integration (ASI)-based physiotherapy intervention in children with cerebral palsy. Thirty children aged 3 to 6 years who meet the eligibility criteria will be assigned to an intervention group or a control group using age- and sex-stratified randomization.
Children in the intervention group will receive ASI-based physiotherapy from a physiotherapist who holds an ASI practitioner certificate. The intervention will last 12 weeks and will consist of three 60-minute sessions per week, for a total of 36 sessions. Children in the control group will continue their usual physiotherapy and rehabilitation. No additional ASI intervention will be provided to the control group as part of the study.
Demographic, perinatal, natal, and postnatal information will be collected using a researcher-developed Demographic Information Form. Before the intervention, sensory functions will be assessed using the Evaluation in Ayres Sensory Integration (EASI). The EASI will be administered at baseline only and will not be repeated after the intervention.
Sensory processing will be assessed using the family-report Sensory Processing Measure (SPM), which evaluates areas including social participation, vision, hearing, taste, smell, touch, movement, body awareness, and planning. Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88). Individualized goals will be established at the start of the intervention in collaboration with the parents using the Goal Attainment Scale (GAS). The Peabody Developmental Motor Scales, Second Edition (PDMS-2), and the Pediatric Evaluation of Disability Inventory (PEDI) will be administered before and after the intervention. Assessments will be conducted in a clinical setting by an assessor independent of the intervention therapists.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Ayres Sensory Integration-Based Physiotherapy, Usual Physiotherapy and Rehabilitation
- Keywords
- Ayres Sensory Integration, Physiotherapy, Sensory Processing, Children, Gross Motor Function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ayres Sensory Integration-Based PhysiotherapyBehavioural
A 12-week Ayres Sensory Integration-based physiotherapy program delivered by a physiotherapist certified in ASI. Children will attend three 60-minute sessions per week, for a total of 36 sessions. Each child will actively participate in individualized, purposeful sensory-motor activities selected and adapted by the therapist to the child's abilities and needs.
Usual Physiotherapy and RehabilitationBehavioural
Children will continue the physiotherapy and rehabilitation care they usually receive. No additional Ayres Sensory Integration-based physiotherapy will be provided as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| ASI-Based Physiotherapy Intervention | Experimental | Children in this group will receive Ayres Sensory Integration (ASI)-based physiotherapy from a physiotherapist certified in ASI. The intervention will last 12 weeks and consist of three 60-minute sessions per week, for a total of 36 sessions. Each child will be expected to actively participate in individualized sensory-motor activities. Activities will be selected and adapted by the therapist to the child's abilities and needs and will encourage active, purposeful engagement. Receives: Behavioral: Ayres Sensory Integration-Based Physiotherapy |
| Usual Care Control | Active comparator | Children in this group will continue their usual physiotherapy and rehabilitation care. They will not receive additional ASI-based physiotherapy as part of the study. Receives: Behavioral: Usual Physiotherapy and Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure-88 (GMFM-88)
Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88). The GMFM-88 assesses lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. The total score will be recorded at baseline and at the end of the 12-week study period. Change from baseline to Week 12 will be compared between groups.
Measured: Baseline and Week 12
Sensory Processing Measure (SPM)
Sensory processing will be assessed using the parent-report Sensory Processing Measure (SPM). Scores will be recorded at baseline and at the end of the 12-week study period. Change from baseline to Week 12 will be compared between groups.
Measured: Baseline and Week 12
Peabody Developmental Motor Scales, Second Edition (PDMS-2)
Motor skills will be assessed using the Peabody Developmental Motor Scales, Second Edition (PDMS-2). Gross motor, fine motor, and total motor scores will be recorded at baseline and at the end of the 12-week study period. Changes from baseline to Week 12 will be compared between groups.
Measured: Baseline and Week 12
Pediatric Evaluation of Disability Inventory (PEDI)
Functional skills will be assessed using the Pediatric Evaluation of Disability Inventory (PEDI), including self-care, mobility, and social function. Scores will be recorded at baseline and at the end of the 12-week study period. Change from baseline to Week 12 will be compared between groups.
Measured: Baseline and Week 12
Goal Attainment Scale (GAS)
Individualized goals will be established in collaboration with the parents at the start of the intervention. Goal attainment will be assessed at the end of the 12-week study period using the Goal Attainment Scale. Each goal will be rated from -2 to +2, with 0 representing the expected level of attainment. The prespecified GAS score will be used for analysis.
Measured: Goals established at baseline; goal attainment assessed at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive Ayres Sensory Integration-based physiotherapy in addition to study assessments. The control group will continue their usual physiotherapy and rehabilitation and will not receive additional ASI as part of the study. An assessor who is independent of the treating therapists and unaware of group assignment will conduct the pre- and post-intervention assessments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izgi Miray Demirbag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Izgi Miray Demirbag, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895485
- Sponsor's protocol ID
- E-10840098-202.3.02-893
- Other IDs
- E-10840098-202.3.02-893
- Acronym
- ASI-CP-PT
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ayres Sensory Integration-Based Physiotherapy in Children With Cerebral Palsy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07895485
- Acronym / sponsor ID
- ASI-CP-PT / E-10840098-202.3.02-893
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Ayres Sensory Integration, Physiotherapy, Sensory Processing, Children, Gross Motor Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Izgi Miray DemirbagUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine whether a 12-week Ayres Sensory Integration (ASI)-based physiotherapy program can improve motor skills and daily functioning in young children with cerebral palsy. Thirty children aged 3 to 6 years who meet the study criteria will be assigned to an intervention group or a control group.
Children in the intervention group will receive 36 sessions of ASI-based physiotherapy over 12 weeks. Each session will last 60 minutes and will be provided by a physiotherapist certified in ASI. Children in the control group will continue their usual physiotherapy and rehabilitation and will not receive additional ASI as part of the study.
Children will be assessed before and after the 12-week study period. Assessments will include measures of motor skills, development, daily activities, sensory processing, and progress toward individual goals. The Evaluation in Ayres Sensory Integration (EASI) will be completed before the intervention only. Assessments will be carried out in a clinical setting by an assessor who is independent of the therapists providing the intervention.
Detailed description
This study will evaluate the effectiveness of an Ayres Sensory Integration (ASI)-based physiotherapy intervention in children with cerebral palsy. Thirty children aged 3 to 6 years who meet the eligibility criteria will be assigned to an intervention group or a control group using age- and sex-stratified randomization.
Children in the intervention group will receive ASI-based physiotherapy from a physiotherapist who holds an ASI practitioner certificate. The intervention will last 12 weeks and will consist of three 60-minute sessions per week, for a total of 36 sessions. Children in the control group will continue their usual physiotherapy and rehabilitation. No additional ASI intervention will be provided to the control group as part of the study.
Demographic, perinatal, natal, and postnatal information will be collected using a researcher-developed Demographic Information Form. Before the intervention, sensory functions will be assessed using the Evaluation in Ayres Sensory Integration (EASI). The EASI will be administered at baseline only and will not be repeated after the intervention.
Sensory processing will be assessed using the family-report Sensory Processing Measure (SPM), which evaluates areas including social participation, vision, hearing, taste, smell, touch, movement, body awareness, and planning. Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88). Individualized goals will be established at the start of the intervention in collaboration with the parents using the Goal Attainment Scale (GAS). The Peabody Developmental Motor Scales, Second Edition (PDMS-2), and the Pediatric Evaluation of Disability Inventory (PEDI) will be administered before and after the intervention. Assessments will be conducted in a clinical setting by an assessor independent of the intervention therapists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive Ayres Sensory Integration-based physiotherapy in addition to study assessments. The control group will continue their usual physiotherapy and rehabilitation and will not receive additional ASI as part of the study. An assessor who is independent of the treating therapists and unaware of group assignment will conduct the pre- and post-intervention assessments.
| Arm | Type | Receives |
|---|---|---|
| ASI-Based Physiotherapy Intervention | Experimental | Behavioral: Ayres Sensory Integration-Based PhysiotherapyChildren in this group will receive Ayres Sensory Integration (ASI)-based physiotherapy from a physiotherapist certified in ASI. The intervention will last 12 weeks and consist of three 60-minute sessions per week, for a total of 36 sessions. Each child will be expected to actively participate in individualized sensory-motor activities. Activities will be selected and adapted by the therapist to the child's abilities and needs and will encourage active, purposeful engagement. |
| Usual Care Control | Active comparator | Behavioral: Usual Physiotherapy and RehabilitationChildren in this group will continue their usual physiotherapy and rehabilitation care. They will not receive additional ASI-based physiotherapy as part of the study. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 3 to 6 years.
- Diagnosis of cerebral palsy, classified as Level I or II according to the Gross Motor Function Classification System (GMFCS).
- Written informed consent provided by a parent or legal guardian.
- No major visual or hearing impairment that would interfere with the assessments or intervention.
Key exclusion criteria (6 listed)
- GMFCS Level III, IV, or V.
- A severe orthopedic condition that could prevent participation in the intervention.
- Uncorrected visual or hearing impairment.
- Use of sedative medication that could affect the assessments or intervention.
- Epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ayres Sensory Integration-Based PhysiotherapyA 12-week Ayres Sensory Integration-based physiotherapy program delivered by a physiotherapist certified in ASI. Children will attend three 60-minute sessions per week, for a total of 36 sessions. Each child will actively participate in individualized, purposeful sensory-motor activities selected and adapted by the therapist to the child's abilities and needs. | Behavioural | ASI-Based Physiotherapy Intervention |
| Usual Physiotherapy and RehabilitationChildren will continue the physiotherapy and rehabilitation care they usually receive. No additional Ayres Sensory Integration-based physiotherapy will be provided as part of the study. | Behavioural | Usual Care Control |
Primary outcome
Gross Motor Function Measure-88 (GMFM-88)
Time frame: Baseline and Week 12
Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88). The GMFM-88 assesses lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. The total score will be recorded at baseline and at the end of the 12-week study period. Change from baseline to Week 12 will be compared between groups.
Sensory Processing Measure (SPM)
Time frame: Baseline and Week 12
Sensory processing will be assessed using the parent-report Sensory Processing Measure (SPM). Scores will be recorded at baseline and at the end of the 12-week study period. Change from baseline to Week 12 will be compared between groups.
Peabody Developmental Motor Scales, Second Edition (PDMS-2)
Time frame: Baseline and Week 12
Motor skills will be assessed using the Peabody Developmental Motor Scales, Second Edition (PDMS-2). Gross motor, fine motor, and total motor scores will be recorded at baseline and at the end of the 12-week study period. Changes from baseline to Week 12 will be compared between groups.
Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: Baseline and Week 12
Functional skills will be assessed using the Pediatric Evaluation of Disability Inventory (PEDI), including self-care, mobility, and social function. Scores will be recorded at baseline and at the end of the 12-week study period. Change from baseline to Week 12 will be compared between groups.
Goal Attainment Scale (GAS)
Time frame: Goals established at baseline; goal attainment assessed at Week 12
Individualized goals will be established in collaboration with the parents at the start of the intervention. Goal attainment will be assessed at the end of the 12-week study period using the Goal Attainment Scale. Each goal will be rated from -2 to +2, with 0 representing the expected level of attainment. The prespecified GAS score will be used for analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ayres Sensory Integration-Based Physiotherapy and Usual Physiotherapy and Rehabilitation in people with Cerebral Palsy (CP), run by Izgi Miray Demirbag.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Izgi Miray Demirbag Demirbağ, MSc. PT (+905516626550, izgi.demirbag@std.medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure-88 (GMFM-88) (time frame: Baseline and Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.